Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED ST
FDA device recall Z-2428-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
- Action taken
- On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DBM
- Quantity affected
- 4,400 total kits
- Distribution
- Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIW
- Date initiated
- 2008-07-29
- Date posted
- 2008-09-19
- Date terminated
- 2011-03-31
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KALLESTAD HEP-2 CELL LINE SUBSTRATE (K810863) | Kallestad Laboratories, Inc. | 1981-04-14 |