remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
FDA Recall Z-2137-2018 · Posted None
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Recalling FirmThermo Fisher
Recall StatusTerminated
Product CodeJTZ
Date Initiated2018-05-04
Date Terminated2018-12-19
Product Quantity67 units
Reason for Recall
Product may fail performance testing for S aureus ATCC 43300.
Firm Action
The firm initiated the recall by letter on 05/04/2018. The letter stated the following:
"Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action."
For questions contact Technical Services Department at 800-255-6730 or 913-888-0939.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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