FDA (Devices) recall action 91148
The FDA (Devices) publishes a recall like this one as 94 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 94 pages.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.
Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.
Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.
Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.
Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.
Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.
Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.
Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.
Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.
Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.
Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.
Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.
Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.
Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.
Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.
Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.
Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.