Z-0830-2023Class II
Etest Clinical Tobramycin Tm 256 US S30, Catalog 412478
bioMerieux, Inc. / initiated 2022-11-09 / Open, Classified
Biomerieux Inc began a recall of ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 on . FDA classified it as Class II and gives the reason as "As the temperature and time out of range was exceeded, product performances cannot be guaranteed". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0830-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- bioMerieux, Inc.
- Product
- Etest Clinical Tobramycin Tm 256 US S30, Catalog 412478
- Product code
- JWY Manual Antimicrobial Susceptibility Test Systems
- Reason for recall
- As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- FDA root cause
- Storage
- Action
- Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.
- Quantity in commerce
- 4 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- UDI/DI 03573026378875, Batch Numbers: 1009434160
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0783-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0784-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0785-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0786-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0787-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0788-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0789-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0790-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0791-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0792-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0793-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0794-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0795-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0796-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0797-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0798-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0799-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0800-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0801-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0802-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0803-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0804-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0805-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0806-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0807-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0808-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0809-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0810-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0811-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0812-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0813-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0814-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0815-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0816-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0817-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0818-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0819-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0820-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0821-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0822-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0823-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0824-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0825-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0826-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0827-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0828-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0829-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0830-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0831-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0832-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0833-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0834-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0835-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0836-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0837-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0838-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0839-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0840-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0841-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0842-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0843-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0844-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0845-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0846-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0847-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0848-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0849-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0850-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0851-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0852-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0853-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0854-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0855-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0856-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0857-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0858-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0859-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0860-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0861-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0862-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0863-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0864-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0865-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0866-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0867-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0868-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0869-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0870-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0871-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0872-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0873-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0874-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0875-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0876-2023 | 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.