| Date Initiated by Firm |
March 24, 2021 |
| Create Date |
April 13, 2021 |
| Recall Status1 |
Terminated 3 on August 02, 2022 |
| Recall Number |
Z-1416-2021 |
| Recall Event ID |
87605 |
| Product Classification |
Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
|
| Product |
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens
Catalog Number: 444213 |
| Code Information |
Lot Numbers/Exp. Date: Lot Number Expiration Date K20-347 1/23/2021 K20-348 1/23/2021 K20-352 1/24/2021 K20-353 1/24/2021 K20-354 1/24/2021 K20-355 1/25/2021 K20-357 1/25/2021 K20-356 1/25/2021 K20-358 1/26/2021 K20-366 1/28/2021 K20-367 1/29/2021 K20-373 1/30/2021 K20-376 1/31/2021 K20-377 1/31/2021 K20-382 2/1/2021 K20-378 2/2/2021 K20-379 2/2/2021 K20-380 2/3/2021 K20-381 2/3/2021 K20-385 2/5/2021 K20-386 2/6/2021 K20-538 3/1/2021 K20-576 3/20/2021 K20-577 3/20/2021 K20-578 3/20/2021 K20-565 3/21/2021 K20-566 3/21/2021 K20-567 3/21/2021 K20-568 3/21/2021 K20-515 3/24/2021 K20-516 3/24/2021 K20-511 3/27/2021 K20-512 3/27/2021 K20-517 3/28/2021 K20-545 3/28/2021 K20-546 3/28/2021 K20-547 3/28/2021 K20-548 3/28/2021 K20-549 3/28/2021 K20-536 3/29/2021 K20-537 3/29/2021 K20-518 4/1/2021 K20-522 4/1/2021 K20-520 4/2/2021 K20-521 4/2/2021 K20-523 4/2/2021 K20-525 4/2/2021 K20-528 4/3/2021 K20-529 4/3/2021 K20-530 4/3/2021 K20-570 4/3/2021 K20-514 4/4/2021 K20-560 4/4/2021 K20-519 4/5/2021 K20-561 4/5/2021 K20-562 4/5/2021 K20-629 4/5/2021 K20-630 4/5/2021 K20-550 4/6/2021 K20-551 4/6/2021 K20-552 4/6/2021 K20-553 4/7/2021 K20-533 4/8/2021 K20-524 4/9/2021 K20-526 4/9/2021 K20-531 4/9/2021 K20-532 4/9/2021 K20-539 4/10/2021 K20-540 4/10/2021 K20-569 4/11/2021 K20-571 4/11/2021 K20-541 4/12/2021 K20-542 4/12/2021 K20-543 4/12/2021 K20-554 4/12/2021 K20-555 4/12/2021 K20-556 4/12/2021 K20-579 4/12/2021 K20-580 4/12/2021 K20-527 4/13/2021 K20-563 4/13/2021 K20-564 4/13/2021 K20-544 4/14/2021 K20-534 4/16/2021 K20-572 4/16/2021 K20-573 4/16/2021 K20-557 4/17/2021 K20-558 4/17/2021 K20-559 4/17/2021 K20-513 4/18/2021 K20-535 4/20/2021 K20-581 4/21/2021 K20-582 4/21/2021 K20-594 4/21/2021 K20-603 4/21/2021 K20-587 4/22/2021 K20-588 4/22/2021 K20-589 4/22/2021 K20-640 4/22/2021 K20-641 4/22/2021 K20-642 4/22/2021 K20-574 4/23/2021 K20-575 4/24/2021 K20-583 4/25/2021 K20-584 4/25/2021 K20-585 4/25/2021 K20-586 4/25/2021 K20-596 4/26/2021 K20-592 4/27/2021 K20-590 4/28/2021 K20-591 4/28/2021 K20-622 4/29/2021 K20-623 4/29/2021 K20-593 4/30/2021 K20-597 5/1/2021 K20-598 5/1/2021 K20-609 5/1/2021 K20-610 5/1/2021 K20-611 5/1/2021 K20-612 5/1/2021 K20-618 5/1/2021 K20-619 5/1/2021 K20-599 5/2/2021 K20-604 5/2/2021 K20-605 5/2/2021 K20-627 5/2/2021 K20-628 5/2/2021 K20-602 5/3/2021 K20-607 5/3/2021 K20-608 5/3/2021 K20-601 5/4/2021 K20-606 5/4/2021 K20-595 5/5/2021 K20-613 5/6/2021 K20-614 5/6/2021 K20-624 5/7/2021 K20-625 5/7/2021 K20-615 5/9/2021 K20-616 5/9/2021 K20-617 5/9/2021 K20-621 5/9/2021 K20-600 5/10/2021 K20-620 5/11/2021 K20-632 5/11/2021 K20-633 5/11/2021 K20-626 5/12/2021 K20-631 5/13/2021 K20-638 5/13/2021 K20-639 5/13/2021 K20-634 5/14/2021 K20-635 5/14/2021 K20-643 5/14/2021 K20-636 5/16/2021 K20-637 5/17/2021 UDI: 382904442132 |
Recalling Firm/
Manufacturer |
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
|
| For Additional Information Contact |
SAME
410-316-4164
|
Manufacturer Reason
for Recall |
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
BD issued Urgent Medical Device Correction letter on March 24, 2021 FedEx tracked. Letter states reason for recall, health risk and action to take:
1. Inspect rehydration buffer tubes prior to use for the specific catalog and lot numbers listed below in Attachment A and destroy any products containing partially filled or empty tubes following your institutions process for destruction.
2. Share and Post this medical device recall notification within your facility network to ensure users inspect tubes prior to use.
3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement, if required.
4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via:
Actions Taken by BD:
1. Corrective actions have been initiated to prevent recurrence of the identified root cause.
2. BD will provide a product replacement for all destroyed inventory.
If you require further assistance, please contact: BD Contact US Contact Information Outside of US BD Customer/ Technical Support
800-638-8663
Monday Friday
7:00am and 7:00pm EST
For customers outside the US, contact the local BD representative or distributor. |
| Quantity in Commerce |
21,529 Kits |
| Distribution |
US Nationwide |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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