Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 25, 2013
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operat
The products may have been stored at temperatures outside their required storage conditions.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Assuramed recalled ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pou… - a moderate-severity action.
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pou… was recalled by Assuramed in September 25, 2013. Reason: The products may have been stored at temperatures outside their required storage conditions.. Check the official notice for the remedy. Verify recall #Z-2198-2013 with the FDA Devices before acting.
The recall
Assuramed issued this moderate-severity FDA Devices recall-The products may have been stored at temperatures outside their required storage conditions..
- Moderate
- severity level
- Class II
- classification
- September 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2198-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2198-2013) was formally reported on September 25, 2013, with the manufacturer initiating the action on July 16, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Assuramed is listed as the recalling firm, operating out of Twinsburg, OH. Federal records list the affected scope as 1) 72 units; 2) 56 units.
The documented reason for this recall is: The products may have been stored at temperatures outside their required storage conditions. Distribution data in the federal record shows the product reached: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1) 72 units; 2) 56 units
Related Recalls
6
3 from same agency
Product description
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.
Reason for recall
The products may have been stored at temperatures outside their required storage conditions.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2198-2013 |
| Date reported | September 25, 2013 |
| Date initiated | July 16, 2013 |
| Recalling firm | Assuramed |
| Firm location | Twinsburg, OH |
| Affected scope | 1) 72 units; 2) 56 units |
| Distribution | Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2198-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.. Recalled by Assuramed. Units affected: 1) 72 units; 2) 56 units.
Why was this product recalled? ▼
The products may have been stored at temperatures outside their required storage conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2198-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2198-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 25, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.