Access Immunoassay Systems Free T4, Part Number: 33880
FDA device recall Z-2658-2010 · posted 2010-10-01 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
- Action taken
- A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled as Vitamin B12 Lot 916277. The PCA requested customers: (1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (2) Inspect your Access Free T4 reagent kit inventory for any reagent packs labeled as Access Vitamin B12, lot 916277 and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (3) Review your historical quality control to ensure that assay performance for Access Vitamin B12 lot 916277 has been within your laboratory specifications. In addition customers were instructed to share this information with their laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that you have received this important notification. If customers need assistance or have any questions regarding the notification, they were instructed to contact Customer Technical Support Center at 1-800-854-3633 in the United States and Canada.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEC
- Quantity affected
- 10826
- Distribution
- Nationwide In the US & Canada
- Date initiated
- 2010-03-24
- Date posted
- 2010-10-01
- Date terminated
- 2012-05-07
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K982250) | Beckman Instruments, Inc. | 1998-07-14 |