MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-06 for BOND AND NOVOCASTRA PA0271,PA0266, CD7 PA0271, PA0266, CD7 manufactured by Leica Biosystems Newcastle Ltd.
[2537587]
(b)(4) was received from a customer in (b)(6) regarding bond rtu cd7 ((b)(4)). It was noted that staining with bond rtu cd7 was giving a different staining pattern to the concentrate version i. E. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9630541]
Internal investigation revealed that cd2 cells were grown as cd7 and likewise, cd7 cells as cd2. Both cd2 and cd7 are membrane markers of most t-cells and nk-cells and are used as part of a panel alongside other t-cell markers. Since cd2 and cd7 expression may vary between reactive t-cell proliferations and t-cell lymphomas, the decision was made to conduct a recall. Pa0271 lots 08173, 11855, 14784, pa0266 lots 10604, 13566, ncl-cd7-580 lots l158018, l158019, l158020. Our course of action is to release a field correction letter to inform all customers of the affected lots of this issue and request any unused product to be returned. Clinicians are also advised that they may wish to review results obtained from these lots. Corrective actions include review of processes in tissue culture production and implement tightened line-clearance procedure to avoid further mix-ups.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2012-00001 |
| MDR Report Key | 2455347 |
| Report Source | 07 |
| Date Received | 2012-02-06 |
| Date of Report | 2011-12-06 |
| Date of Event | 2011-12-05 |
| Date Added to Maude | 2012-08-14 |
| 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 Street | BALLIOL BUSINESS PARK BENTON LANE |
| Manufacturer City | NEWCASTLE UPON TYNE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer Phone | 912150567 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOND AND NOVOCASTRA |
| Generic Name | IMMUNOHISTOCHEMISTRY REAGEANT |
| Product Code | NJT |
| Date Received | 2012-02-06 |
| Model Number | PA0271,PA0266, CD7 |
| Catalog Number | PA0271, PA0266, CD7 |
| Lot Number | VARIOUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Address | BALLIOL BUSINESS PARK BENTON LANE NEWCASTLE UPON TYNE NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-06 |