Z-1038-2024Class II
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number...
Becton Dickinson & Co / initiated 2024-01-08 / Open, Classified / root cause: manufacturing process
Becton Dickinson & Co. began a recall of BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544 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-1038-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Becton Dickinson & Co
- Product
- BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544
- 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. 231541 UDI-DI 00382902315414 Lots 1278110 1334479 2004554 2025125 2056466 2242510 3214931; Catalog No. 231544¿ UDI-DI 30382902315446 Lots 1116055 1211489 2339407 3030278 3158059 3214931 0343413 1032232 1088790 1148547 1278110 1334479 2004554 2025125 2056466 2090443 2242510
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1011-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1012-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1013-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1014-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1015-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1016-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1017-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1018-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1019-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1020-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1021-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1022-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1023-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1024-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1025-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1026-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1027-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1028-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1029-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1030-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1031-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1032-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1033-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1034-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1035-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1036-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1037-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1038-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1039-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1040-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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