MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-01 for BLOOD GROUPING REAGENT ANTI-S (MNS3) 808052100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1920649]
This report concerns two batches of seraclone anti-s, art. No. (b)(4). In addition to the lot number, the lot 7025110-01 (exp date 06/12/2012) is affected as well. The customer reported false negative reactions of s positive cells from their cell panel of a competitor. The panel cells are used as control cells. The customer has sent us the two complained lots but not the panel cells. The two complaint samples of customer were tested with different s positive red cells and reacted correctly positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00025 |
| MDR Report Key | 2024207 |
| Report Source | 05 |
| Date Received | 2011-02-01 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-01-31 |
| Date Mfgr Received | 2011-02-03 |
| Date Added to Maude | 2011-04-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR MARC GORZELLIK |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63303 |
| Manufacturer Phone | 103801528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD GROUPING REAGENT ANTI-S (MNS3) |
| Generic Name | SERACLONE ANTI-S (MNS3) |
| Product Code | LKJ |
| Date Received | 2011-02-01 |
| Returned To Mfg | 2011-02-15 |
| Catalog Number | 808052100 |
| Lot Number | 7002130-01 |
| Device Expiration Date | 2012-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-01 |