GEM Premier 5000 PAK Recall Issued by Instrumentation Laboratory
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Instrumentation Laboratory is recalling 109 units of GEM Premier 5000 PAK devices due to incorrect active ingredient concentration in the lysing bag solution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Which Products Are Affected
GEM Premier 5000 PAK, Part Numbers: 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, 00055445010, 00055445011, 00055360010.A. Affected lots include 260505K, 260504AG, 260505F, 260505J, 260505R, 260505H, 260504AA, 260504AF. A total of 109 units are affected. Distribution includes US states AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and countries China, Germany, Italy.
What You Should Do
Contact Instrumentation Laboratory regarding the recall.
Why This Matters
The recall affects medical devices used for Co-Oximetry and total bilirubin testing worldwide.
Source
FDA recall number Z-2900-2026, event ID 99128.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,005 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.