BD MULTI-CHECK CD4 LOW CONTROL
Received Aug 29, 2023 · Event occurred Aug 2, 2023
Report 2243072-2023-01523 · MDR key 17644382
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
340914
Lot number
BM0823L
Product problems
- Wrong Label
- Wrong Label
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN.
Additional Manufacturer Narrative
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.5. PMA / 510(K)#: K150815. G.5. PMA / 510(K)#: K982231. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2243072-2023-01523 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. H3 OTHER TEXT : SEE H.10.