AFINION HBA1C
Received Nov 27, 2024 · Event occurred Sep 10, 2024
Report 20796097 · MDR key 20796097
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Abbott Diagnostics Technologies AsModel number
1116974Catalog number
1116974
Lot number
10228265
Product problems
- Device Markings/Labelling Problem
Patient
NA · Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
[REDACTED NAME] RECEIVED A BOX OF HGBA1C TESTS WITH NO LOT NUMBERS OR EXPIRATION DATES. THE LOT NUMBERS ARE USUALLY FOUND ON THE OUTSIDE BOX AND THE INDIVIDUAL POUCHES. THERE ARE NO LOT NUMBERS ON THE CARTRIDGES INSIDE THE POUCHES. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND. MANUFACTURER RESPONSE FOR HEMOGLOBIN A1C TESTS, (BRAND NOT PROVIDED) (PER SITE REPORTER) VIA OUR DISTRIBUTOR MCKESSON. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND.
Description of Event or Problem
[REDACTED NAME] RECEIVED A BOX OF HGBA1C TESTS WITH NO LOT NUMBERS OR EXPIRATION DATES. THE LOT NUMBERS ARE USUALLY FOUND ON THE OUTSIDE BOX AND THE INDIVIDUAL POUCHES. THERE ARE NO LOT NUMBERS ON THE CARTRIDGES INSIDE THE POUCHES. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND. MANUFACTURER RESPONSE FOR HEMOGLOBIN A1C TESTS, (BRAND NOT PROVIDED) (PER SITE REPORTER) VIA OUR DISTRIBUTOR MCKESSON. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND.
Description of Event or Problem
[REDACTED NAME] RECEIVED A BOX OF HGBA1C TESTS WITH NO LOT NUMBERS OR EXPIRATION DATES. THE LOT NUMBERS ARE USUALLY FOUND ON THE OUTSIDE BOX AND THE INDIVIDUAL POUCHES. THERE ARE NO LOT NUMBERS ON THE CARTRIDGES INSIDE THE POUCHES. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND. MANUFACTURER RESPONSE FOR HEMOGLOBIN A1C TESTS, (BRAND NOT PROVIDED) (PER SITE REPORTER) VIA OUR DISTRIBUTOR MCKESSON. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND.
Description of Event or Problem
[REDACTED NAME] RECEIVED A BOX OF HGBA1C TESTS WITH NO LOT NUMBERS OR EXPIRATION DATES. THE LOT NUMBERS ARE USUALLY FOUND ON THE OUTSIDE BOX AND THE INDIVIDUAL POUCHES. THERE ARE NO LOT NUMBERS ON THE CARTRIDGES INSIDE THE POUCHES. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND. MANUFACTURER RESPONSE FOR HEMOGLOBIN A1C TESTS, (BRAND NOT PROVIDED) (PER SITE REPORTER) VIA OUR DISTRIBUTOR MCKESSON. [REDACTED DATE] SITE CONFIRMED THIS COMES THROUGH MCKESSON AND HAS BEEN ESCALATED TO MCKESSON AND ABBOTT. AS OF TODAY, A REPLACEMENT BOX IS BEING SENT OUT. WHEN ASKED IF [REDACTED NAME] SHOULD BE LOOKING AT OTHER SITES THAT PURCHASE THIS PRODUCT AND IF THIS IS A KNOWN ISSUE, ABBOTT DID NOT RESPOND.