Recall archive / FDA device enforcement
Accelerate PhenoTest BC kit REF 10102018 — FDA record Z-0346-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Accelerate PhenoTest BC kit REF 10102018
- Reason
- Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
- Classification
- Class II
- Recalling firm
- Accelerate Diagnostics Inc
- Quantity
- 7,160 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0346-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 7, 2022
- Recall initiation date
- Oct 17, 2022
- Center classification date
- Nov 30, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.