PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalo
FDA device recall Z-1001-2015 · posted 2015-01-20 · Terminated
Recall details
- Recalling firm
- Genetic Testing Institute,inc
- Reason for recall
- Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
- Action taken
- Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LCO
- Quantity affected
- 6206 kits
- Distribution
- Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK,
- Date initiated
- 2014-12-15
- Date posted
- 2015-01-20
- Date terminated
- 2015-04-30
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PF4 ENHANCED SOLID PHASE ELISA (K053559) | Genetic Testing Institute | 2006-01-20 |