MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-05-19 for CAPTURE-CMV INDICATOR RED CELLS 0066238 manufactured by Immucor, Inc..
[2005444]
Customer reported unexpected negative reactions with capture-cmv on the galileo. When re-testing samples, they found that 6 previously negative results resulted positive when tested with a new lot number of capture-cmv indicator red cells.
Patient Sequence No: 1, Text Type: D, B5
[9121166]
A market withdrawal regarding capture-cmv indicator red cells lot 228143, exp 2011-04-29, was released to customers on 11apr2011. The market withdrawal was issued to cover the weaker reactivity that the lot was demonstrating. No confirmatory testing was performed to determine whether results initial results or repeat testing results are correct. No samples were returned to manufacturer for serological testing. Immucor has made several attempts to retrieve images and samples; however, customer is unable to provide the requested file images or additional sample for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2011-00057 |
| MDR Report Key | 2096609 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-05-19 |
| Date of Event | 2011-04-19 |
| Date Mfgr Received | 2011-04-19 |
| Device Manufacturer Date | 2009-08-04 |
| Date Added to Maude | 2012-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 5625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-CMV INDICATOR RED CELLS |
| Generic Name | ANTI-IGG COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS |
| Product Code | LJO |
| Date Received | 2011-05-19 |
| Catalog Number | 0066238 |
| Lot Number | 228143 |
| Device Expiration Date | 2011-04-29 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091562 US 30091 5625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-19 |