Z-1031-2024Class II
BD BBL Sensi Disc Imipenem- 10 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 Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645 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-1031-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Becton Dickinson & Co
- Product
- BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645
- 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. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950; Catalog No. 231645¿ UDI-DI 30382902316450 Lots 3062101 3094134 3118125 3214950 3261103 1335006 2056580 2081151 2091918 2091925 2147704 2210318 2210343 2277500 2301385
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.