Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Reported: August 25, 2021 Initiated: May 27, 2021 #Z-2323-2021
Product Description
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Reason for Recall
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Details
- Recalling Firm
- Cytocell Ltd.
- Units Affected
- 23 units
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
- Location
- Cambridge, N/A
Frequently Asked Questions
What product was recalled? ▼
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's). Recalled by Cytocell Ltd.. Units affected: 23 units.
Why was this product recalled? ▼
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2323-2021.
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