BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Pro
FDA device recall Z-0028-2014 · posted 2013-10-19 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
- Action taken
- BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 187,000 tubes
- Distribution
- USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
- Date initiated
- 2013-09-09
- Date posted
- 2013-10-19
- Date terminated
- 2013-10-29
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACTEC MGIT 960 SYSTEM (K974883) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-01 |