MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2004-09-20 for BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT 240909 manufactured by Genzyme Corp..
[36482686]
The bd colorpac cryptosporidium/giardia test kit is an oem (original equipment manufacturer) from (b)(4). Bd was notified in february / march 2004, that (b)(4) had identified two kit lots that should be recalled: 071093 and 071138 respectively, due to an increase in false positive cryptosporidium results. Only the kit lot 071093 was distributed by bd. This kit lot was recalled by bd in march 2004. The (b)(4) district office was also informed of the product recall. At the time of the recall, a vendor corrective / preventive action report ((b)(4)) was sent to (b)(4) to address the false positive cryptosporidium issue. Bd and (b)(4) agreed to a corrective action plan; following is a summary: continue testing kits according to current qc release procedure, implement supplemental kit testing of a panel of at least 20 ova & parasite negative stoll specimens, weekly teleconferences with bd to review false positive investigation results and action item, bd performed vendor audit at facility, revise product insert to provide more direct instructions on correct test interpretation. A copy of the health professionals' medwatch form has been forwarded to the vendor. The vendor has submitted a status report for their recall, z-770-4, to the (b)(4) district office of the us food and drug administration. This report has requested closure of the recall based on the vendor corrective actions.
Patient Sequence No: 1, Text Type: N, H10
[36482687]
Received medwatch from health professional. Medwatch referenced performance issues with the bd colorpac giardia/cryptosporidium test kit and the customer's study findings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2004-00005 |
| MDR Report Key | 5323393 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2004-09-20 |
| Date of Report | 2004-09-17 |
| Date of Event | 2004-08-26 |
| Date Mfgr Received | 2004-08-26 |
| Date Added to Maude | 2015-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-770-4 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT |
| Generic Name | ANTIGEN TEST KIT |
| Product Code | MHJ |
| Date Received | 2004-09-20 |
| Model Number | NA |
| Catalog Number | 240909 |
| Lot Number | 071260 |
| Device Expiration Date | 2005-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GENZYME CORP. |
| Manufacturer Address | 500 KENDALL ST. CAMPBRIDGE MA 02142 US 02142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-20 |