GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500
Summary
The FDA issued a Class II for GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243075 by Instrumentation Laboratory. Reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range .
Details
Source
Device Recall
External ID
Z-0358-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Lot/Code Info: Part No. 00024307507: UDI-DI: 08426950087946, Lot Numbers: 323031H, 323531D, 324231M, 325031D, 324931F, 323831E, 323031I, 324231I, 324831E, 325631C; Part No. 00024315007: UDI-DI: 08426950082484, Lot Numbers: 323441B, 323641G, 323041H, 323541D, 324141J, 324841E, 325041D, 325641C; Part No. 00024330007: UDI-DI: 08426950082514, Lot Numbers: 323051H, 323551D, 323651G, 324151J; Part No. 00024345007: UDI-DI: 08426950082545, Lot Numbers: 323761H; Part No. 00024360007: UDI-DI: 08426950082569, Lot Numbers: 323771H, 323471B, 324871E;
Quantity Affected: 2448 units
Reason for Recall
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
Distribution
US States: MA, MN, NY. India.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-29
Company
Bedford, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0358-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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