Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and
FDA device recall Z-0513-2014 · posted 2013-12-16 · Terminated
Recall details
- Recalling firm
- Microgenics Corp
- Reason for recall
- Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
- Action taken
- Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact mgc@thermofisher.com. For question regarding this recall call 1-800-232-3342.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LFW
- Quantity affected
- 370 units
- Distribution
- Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
- Date initiated
- 2013-10-16
- Date posted
- 2013-12-16
- Date terminated
- 2014-02-03
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEDIA(R) TOBRAMYCIN ASSAY (K912143) | Microgenics Corp. | 1991-07-26 |