STA Neoplastine CI Plus (10), (cat. 0667) recallZ-0979-2007 · Diagnostica Stago, Inc. · initiated Mar 30, 2007
Terminated All recalls posted in July 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
FDA root cause category: Other
What the company is doing
Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
Recall details
- Recall number
- Z-0979-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 30, 2007
- Posted by the FDA
- Jul 3, 2007
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 170 units
- Product code
- GJS
- FDA submissions
- K922040
- Distribution
- Nationwide.
Product description
STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Code information (models, lots, serial numbers)
Lot 061781, June 2008
Other devices under the same FDA submission
1 device cleared under K922040 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STA® - Néoplastine® CI Plus 10 00667Diagnostica Stago · TEST, TIME, PROTHROMBIN1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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