Recall Z-0880-2015— Alere San Diego, Inc.
Class I · Terminated
Class I FDA medical device recall by Alere San Diego, Inc., initiated 2014-12-05, terminated 2017-09-18. It names 5 FDA 510(k) clearances: K110212, K092987, K072727 and 2 more. Product: Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).. Reason: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed..
- Recalling firm
- Alere San Diego, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-12-05
- Terminated
- 2017-09-18
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
- K092987 — INRATIO/INRATIO2 TEST STRIPS
- K072727 — INRATIO 2 PT MONITORING SYSTEM
- K021923 — INRATIO SELF-TEST
- K020679 — INRATIO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
Reason for recall
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.