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
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. recalled 21,529 kits of BioGX SARS-CoV-2 Reagents for BD MAX System, a PCR test used to detect SARS-CoV-2 virus in nasopharyngeal specimens. The rehydration buffer tubes in these kits were not adequately sealed, causing some tubes to arrive partially filled or empty when received. When a rehydration buffer tube is partially filled or empty, the BD MAX System may produce an Unresolved (UNR) test result instead of a valid result.
The affected kits were distributed nationwide and include multiple lot numbers with expiration dates ranging from January 23, 2021 through April 13, 2021. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: US Nationwide Quantity: 21,529 Kits Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.