BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The f
FDA device recall Z-2598-2018 · posted 2018-07-13 · Terminated
Recall details
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Reason for recall
- The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
- Action taken
- The firm, BD Life Sciences, produced the "URGENT PRODUCT RECALL-CORRECTION" letter dated 4/6/2018 to its customers during an on-site visit. by the field service engineer made beginning 5/16/2018 to correct the issue. The visits were completed 6/15/2018. If you require further assistance, contact BD Customer/Technical Support BD Customer Support at 877.232.8995 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OYE
- Quantity affected
- 8 devices
- Distribution
- US Distribution was made to FL, KS, KY, MA, NJ, and SD.
- Date initiated
- 2018-05-16
- Date posted
- 2018-07-13
- Date terminated
- 2018-08-13
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (K170974) | Becton, Dickinson and Company | 2017-07-03 |