Z-1040-2024Class II
BD BBL Sensi Disc Tetracycline 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 Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344 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-1040-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Becton Dickinson & Co
- Product
- BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344
- 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. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3263267 9009914 9046895 0065366 0178210; Catalog No. 231344¿ UDI-DI 30382902313442 Lots 3010027 3062263 3094187 3158029 3212760 3263267 3275644 0065366 0085202 0230453 0274792 0335906 1095603 1148539 1180271 1242880 1277918 1301570 2025088 2056233 2089874 2118569 2276681 8355562 9009914 9046895 9130797 9239639 9263061
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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