Food, drugs, devices › TEM Systems Inc
Device recall: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation pro
TEM Systems Inc (Durham, NC) initiated this device recall on 13 Sep 2016; FDA lists 1 product record under event 75265, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 5 Dec 2017. Initiation: voluntary: firm initiated. TEM Systems Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TEM Systems Inc, Durham, NC.
Reason for recall
"Customers complained of low/empty reagent vials."
Distribution
"Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0302-2017 | ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta. | 637 boxes x 10 vials | Class II | Terminated | 2 Nov 2016 |
Context
Other enforcement events for TEM Systems Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Feb 2016 | ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material f | Device | Class II | 1 |
| 23 Oct 2014 | ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. | Device | Class II | 1 |
All 3 events for TEM Systems Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Customers complained of low/empty reagent vials."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.