Z-1026-2024Class II
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog...
Becton Dickinson & Co / initiated 2024-01-08 / Open, Classified / root cause: manufacturing process
Becton Dickinson & Co. began a recall of BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733and 231274 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-1026-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Becton Dickinson & Co
- Product
- BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733and 231274
- 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. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758; Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993
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.