openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Code information
GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;
Distribution pattern
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
device · product 2 of 3
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Code information
GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
Distribution pattern
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
device · product 3 of 3
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Code information
GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;
Distribution pattern
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
