bioMerieux, Inc. Issues Urgent Expanded Product Recall for VITEK® 2 Piperacillin/Tazobactam Test on Gram Negative Susceptibility Cards

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Apr 08, 2011, 09:39 ET

DURHAM, N.C., April 8, 2011 /PRNewswire/ -- As a follow up to the communication issued on September 16, 2010, bioMerieux, Inc. is voluntarily expanding its worldwide product recall of VITEK^® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZP2). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK^® 2 System. Clinical laboratories have been notified to perform an alternative method of testing prior to reporting results for:

Piperacillin/Tazobactam (TZP2) and Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa and Salmonella enterica
Piperacillin/Tazobactam (TZP2) and Klebsiella pneumoniae with resistant results

bioMerieux has provided instructions to its customers informing them that VITEK^® 2 susceptibility testing results for TZP2 for the organisms listed above are potentially inaccurate and should not be reported. An alternative method should be used for testing and reporting Piperacillin/Tazobactam susceptibility. Customers can continue to use the VITEK^® 2 Gram Negative Susceptibility cards for other antibiotics and for TZP2 testing of Acinetobacter baumannii, Citrobacter koseri, Serratia marcescens and Klebsiella pneumoniae with susceptible results.

The previous product correction notification (410874) informed users that due to performance issues, users should test all E. coli strains (regardless of VITEK^® 2 results), and Klebsiella pneumoniae with resistance by VITEK^® 2 testing by an alternative method prior to reporting susceptibility results. A subsequent internal investigation conducted by bioMerieux determined that VITEK^® 2 Gram Negative Susceptibility cards may also incorrectly determine M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P aeruginosa and S. enterica susceptibility such that susceptible isolates may be reported as resistant to Piperacillin/Tazobactam (TZP2), and resistant isolates reported as susceptible to Piperacillin/Tazobactam (TZP2). The current expanded recall is based on these findings. This investigation also confirmed the previously identified performance issues with E. coli and K. pneumoniae testing.

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli, M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P. aeruginosa or S. enterica isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible results for Piperacillin/Tazobactam (TZP2) and isolates of these specific organisms, or for falsely-resistant K. pneumoniae results.

Included below is a list of VITEK^® 2 Gram Negative Susceptibility cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK^® 2 Gram Negative Susceptibility cards created that contain TZP2 are affected by this product correction.

bioMerieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMerieux, Inc. at 1-800-682-2666, option 3; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.

Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMerieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm; or by fax at 1-800-FDA-0178.

About bioMerieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for over 45 years, bioMerieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2010, revenues reached euro 1.357 billion with 87% of sales outside of France.

bioMerieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMerieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).
Other information can be found at www.biomerieux.com.

List of all currently available test cards that contain TZP2


Cards Distributed outside the U.S. only						Cards Distributed Globally (including U.S.)
Card Name	Ref. #	Card Name	Ref. #	Card Name	Ref. #	Card Name	Ref. #
AST-N080	22214	AST-N117	22290	AST-N152	22347	AST-GN22	22227
AST-N081	22215	AST-N118	22291	AST-N153	22348	AST-GN23	22228
AST-N082	22217	AST-N120	22293	AST-N155	22352	AST-GN24	22229
AST-N084	22224	AST-N121	22295	AST-N156	22353	AST-GN25	22230
AST-N085	22225	AST-N122	22299	AST-N157	22354	AST-GN26	22244
AST-N086	22234	AST-N123	22301	AST-N158	22355	AST-GN27	22245
AST-N087	22235	AST-N124	22303	AST-N159	22356	AST-GN28	22254
AST-N088	22236	AST-N127	22308	AST-N160	22357	AST-GN29	22266
AST-N089	22237	AST-N128	22309	AST-N161	410026	AST-GN30	22267
AST-N090	22240	AST-N129	22310	AST-N162	410023	AST-GN31	22268
AST-N091	22241	AST-N130	22311	AST-N163	410084	AST-GN32	22269
AST-N093	22243	AST-N131	22315	AST-N164	410101	AST-GN33	22270
AST-N093	22246	AST-N132	22316	AST-N165	410102	AST-GN34	22271
AST-N094	22247	AST-N133	22318	AST-N166	410136	AST-GN35	22286
AST-N095	22249	AST-N134	22319	AST-N167	410138	AST-GN36	22300
AST-N096	22250	AST-N135	22322	AST-N168	410139	AST-GN37	22312
AST-N097	22251	AST-N136	22323	AST-N170	410222	AST-GN39	22337
AST-N098	22253	AST-N137	22324	AST-N171	410249	AST-GN40	410756
AST-N100	22256	AST-N138	22326	AST-N172	410298	AST-GN41	410757
AST-N103	22259	AST-N139	22327	AST-N174	410404	AST-GN42	410758
AST-N104	22261	AST-N140	22328	AST-N175	410403	AST-GN43	410759
AST-N105	22262	AST-N141	22329	AST-N176	410402	AST-GN44	410805
AST-N106	22264	AST-N142	22332	AST-N177	410392
AST-N107	22265	AST-N143	22333	AST-N178	410393
AST-N108	22272	AST-N144	22334	AST-N179	410640
AST-N109	22273	AST-N145	22338	AST-N180	410771
AST-N110	22274	AST-N146	22341	AST-N181	410803
AST-N111	22275	AST-N147	22342	AST-N182	410804
AST-N112	22281	AST-N148	22343	AST-N183	411021
AST-N114	22283	AST-N149	22344	AST-N184	411154
AST-N115	22285	AST-N150	22345
AST-N116	22289	AST-N151	22346