Recall Z-1362-2019— Abbott Laboratories
Class III · Terminated
Class III FDA medical device recall by Abbott Laboratories, initiated 2019-04-09, terminated 2019-12-20. It names one FDA 510(k) clearance: K132751. Product: Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.. Reason: Devices were delivered without the required dry ice..
- Recalling firm
- Abbott Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-09
- Terminated
- 2019-12-20
- Firm location
- Abbott Park, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Reason for recall
Devices were delivered without the required dry ice.
Data sourced from openFDA. This site is unofficial and independent of the FDA.