510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1016-2024Class II

BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog...

Becton Dickinson & Co / initiated 2024-01-08 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Becton Dickinson & Co. began a recall of BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641 on . FDA classified it as Class II and gives the reason as "There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1016-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Becton Dickinson & Co
Product
BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.
Product code
JTN Susceptibility Test Discs, Antimicrobial
Reason for recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On January 8, 2024, the firm notified customers through URGENT Medical Device Product Correction letters. Users were instructed to cease use of catalog number 291270, and to refrain from conducting AST for H. influenzae with impacted Sensi-Discs. Customers should destroy any units of catalog number 291270 in their inventory. Customers should share and post the recall notification within their facility network and forward to any customers to whom they may have distributed the product. Future lots of affected Sensi-Disc products (excluding catalog number 291270) will be labeled with a sticker notifying customers "This product should not be used for the semi-quantitative in vitro susceptibility testing of Haemophilus influenzae." Identify impacted lot numbers: https://legacy.bd.com/alerts-notices/IDS-23-4851.asp For customer questions: Phone: 1-844-823-5433 Say "Recall when prompted Mon-Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce
2,363,168 total units
Distribution
Domestic distribution nationwide. International distribution worldwide.
Product codes and lots
Catalog No. 231640¿ UDI-DI 00382902316404 Lots 1117192 1211613 1243750 1278287 3214945; Catalog No. ¿231641 UDI-DI 30382902316412 Lots 2304491 3093375 3184116 3214945 3261101 3282901 1117192 1211613 1278287 1305148 2004458 2028924 2090502 2244457

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1016-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1011-2024Class IIOngoingVoluntary: Firm initiated
Z-1012-2024Class IIOngoingVoluntary: Firm initiated
Z-1013-2024Class IIOngoingVoluntary: Firm initiated
Z-1014-2024Class IIOngoingVoluntary: Firm initiated
Z-1015-2024Class IIOngoingVoluntary: Firm initiated
Z-1016-2024Class IIOngoingVoluntary: Firm initiated
Z-1017-2024Class IIOngoingVoluntary: Firm initiated
Z-1018-2024Class IIOngoingVoluntary: Firm initiated
Z-1019-2024Class IIOngoingVoluntary: Firm initiated
Z-1020-2024Class IIOngoingVoluntary: Firm initiated
Z-1021-2024Class IIOngoingVoluntary: Firm initiated
Z-1022-2024Class IIOngoingVoluntary: Firm initiated
Z-1023-2024Class IIOngoingVoluntary: Firm initiated
Z-1024-2024Class IIOngoingVoluntary: Firm initiated
Z-1025-2024Class IIOngoingVoluntary: Firm initiated
Z-1026-2024Class IIOngoingVoluntary: Firm initiated
Z-1027-2024Class IIOngoingVoluntary: Firm initiated
Z-1028-2024Class IIOngoingVoluntary: Firm initiated
Z-1029-2024Class IIOngoingVoluntary: Firm initiated
Z-1030-2024Class IIOngoingVoluntary: Firm initiated
Z-1031-2024Class IIOngoingVoluntary: Firm initiated
Z-1032-2024Class IIOngoingVoluntary: Firm initiated
Z-1033-2024Class IIOngoingVoluntary: Firm initiated
Z-1034-2024Class IIOngoingVoluntary: Firm initiated
Z-1035-2024Class IIOngoingVoluntary: Firm initiated
Z-1036-2024Class IIOngoingVoluntary: Firm initiated
Z-1037-2024Class IIOngoingVoluntary: Firm initiated
Z-1038-2024Class IIOngoingVoluntary: Firm initiated
Z-1039-2024Class IIOngoingVoluntary: Firm initiated
Z-1040-2024Class IIOngoingVoluntary: Firm initiated