device · product 1 of 1
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
- Recall number
- Z-1416-2021
- Initiated
- March 24, 2021
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 21,529 Kits
App-derived interpretation
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
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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
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
Distribution pattern
US Nationwide