MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[52416086]
Included in the recall of the device is the donorscreen-hla class i and class ii additional reagents packaging. The additional reagents are available to customers who run the assay as individual strips instead of full plates. There is no failure associated with the additional reagents themselves but due to them being lot specific to the donorscreen-hla class i and class ii assay being recalled, these reagents are directed to be disposed and will be replaced where applicable.
Patient Sequence No: 1, Text Type: N, H10
[52416087]
A product complaint was received, (b)(4) from (b)(46 claiming that 3 invalid runs were obtained with donorscreen-hla class i and class ii assay; lot 3002728a/3002728b. Two runs were invalid due to increased od for the negative serum control-class i. One run was invalid due to decreased od for the positive serum control-class ii. Internal testing at immucor on (b)(6) 2016 did not reproduce the complaint. Further testing was performed on (b)(6) 2016 using full plates of the assay. The failure observed with negative serum control-class i was confirmed. The failure observed with positive serum control-class ii was not confirmed. Confirmation testing was performed on (b)(6) 2016 to confirm the failure seen with the negative serum control-class i. The failure was only seen when running full plates of the assay and not when running individual or partial plates (1-3 strips). Additional investigation testing confirmed only full plate assays were exhibiting the failure. No other lots of product have been identified to exhibit this failure.
Patient Sequence No: 1, Text Type: D, B5
[55227024]
First follow-up report. Manufacture date corrected to 06/15/2015. Initial action initiated: changed to "other". Cber categorized action as a market withdrawal, not a recall as provided in original report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183608-2016-00003 |
| MDR Report Key | 5846833 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-06-17 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2016-08-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULIE EWEND |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONORSCREEN-HLA CLASS I AND CLASS II |
| Generic Name | DONORSCREEN-HLA CLASS I AND CLASS II |
| Product Code | MZI |
| Date Received | 2016-08-04 |
| Model Number | NA |
| Catalog Number | DSI+II |
| Lot Number | 3002728A |
| Device Expiration Date | 2017-04-15 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 531864054 US 531864054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-04 |