Recalls / —

—#186392

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

FDA product code

QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid

Device class

Class N

Medical specialty

Unknown

Affected 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 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Co.

Address

7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern

US Nationwide

Timeline

Recall initiated

2021-03-24

Terminated

2022-08-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #186392. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.