| Date Initiated by Firm | December 16, 2005 |
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| Date Posted | February 04, 2006 |
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| Recall Status1 |
Terminated 3 on June 30, 2006 |
| Recall Number | Z-0470-06 |
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| Recall Event ID |
34263 |
| 510(K)Number | K841272 |
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| Product Classification |
Test, Sickle Cell - Product Code GHM
|
| Product | Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml. |
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| Code Information |
Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06 |
| FEI Number |
2431980
|
Recalling Firm/
Manufacturer |
Chembio Diagnostic System Inc
3661 Horseblock Road
Medford NY 11763-2215
|
| For Additional Information Contact | Thomas D. Ippolito
631-924-1135 Ext. 122 |
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Manufacturer Reason
for Recall | Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations. |
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FDA Determined
Cause 2 | Other |
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| Action | Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05. |
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| Quantity in Commerce | Lot SC050305: 347 test kits, Lot SC062805: 410 test kits |
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| Distribution | Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine) |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = GHM
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