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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Becton Dickinson & Co.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1416-2021
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Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.